Label: BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE- benzoyl peroxide soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 23, 2020

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  • DOSAGE & ADMINISTRATION

    Directions: use 1 to 3 times daily for oily skin and scalp; apply with fingertips, using circular motion; gently scrub into a lather; rinse off thoroughly with warm water; if going outside, use a sunscreen

  • WARNINGS

    Warnings: For External Use Only

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Disodium Cocoamyphodiacetate, Glycerin, Ethoxydiglycol, Cocoamidopropyl Betaine, Acrylates C10-20 Alkyl Acrylates Crosspolymer, Disodium EDA, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Polyacrylmide, C13-14 Isoparaffin, Laureth-7, Ethylhexylglycerin, Phenoxyethanol

  • INDICATIONS & USAGE

    Uses: treats acne and helps prevent new acne blemishes from forming; kills acne bacteria

  • PURPOSE

    Treats acne and prevents new acne blemishes from forming

  • ACTIVE INGREDIENT

    Active Ingredients: Benzoyl Peroxide 2.5%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

  • ASK DOCTOR

    Consult a doctor: if excessive irritation occurs

  • OTHER SAFETY INFORMATION

    Other Information: store at room temperature; keep tightly closed

  • PRINCIPAL DISPLAY PANEL

    Benzoyl Acne Wash -2.5%

  • INGREDIENTS AND APPEARANCE
    BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-009-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-009-08240 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    3NDC:70367-009-7522.2 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
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